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This study will evaluate whether Suvorexant 20mg reduces drug use and craving, and improves sleep and stress among persons with co-occurring opioid use disorder and stimulant use disorder.
This between-subjects, double-blinded, randomized controlled pilot study will recruit patients who are receiving methadone or buprenorphine treatment for OUD and are using cocaine. Participants will be randomly assigned to receive up to 30-days of Suvorexant (SUVO) or placebo. They will visit the clinic regularly to provide urine drug screens and complete questionnaires and will wear a device that can measure their sleep parameters. We expect that relative to persons who receive placebo, individuals who receive SUVO will 1) be less likely to screen positive for cocaine and/or opioids on urine drug screens, 2) will report lower drug craving, 3) will have longer total sleep time, 4) will report fewer insomnia symptoms, and 5) will report overall lower stress than persons who receive placebo. We also expect that patients will not have side effects from SUVO. These preliminary data will inform whether this FDA-approved medication may help patients stop co-using opioids and stimulants, which can be scaled up to reduce public health consequences related to co-use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suvorexant | Active Comparator | 20mg Suvorexant |
|
| Placebo | Placebo Comparator | Placebo oral capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suvorexant (dual orexin receptor antagonist) | Drug | Participants will be prescribed up to 30 days of SUVO. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use: Proportion of Positive Urine Drug Screens (UDS) | Opioid use (measured via uranalysis for qualitative opioid assay) other than prescribed methadone or buprenorphine at scheduled study visits up to 30 days post-randomization (yes vs. no) | Up to 30 days post-randomization |
| Cocaine Use: Proportion of Positive UDS Screens | Cocaine use (measured via uranalysis for qualitative cocaine assay) at scheduled study visits up to 30 days post-randomization. | Up to 30 days post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Regression Slope | Regression slope of Insomnia Severity Index (ISI) scores over scheduled study visits through 30 days post-randomization. Total score range between 0-28 (absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). Higher score worse insomnia. | Up to 30 days post-randomization |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Ellis, Ph.D. | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
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A total of 41 individuals attended a screening visit. Of the 20 individuals enrolled (i.e., initially determined as eligible to be scheduled for randomization), 5 declined enrollment and 2 no longer met criteria at the randomization visit and were not randomized.
A total of 13 individuals were randomized. 12 of these individuals completed the study, one individual did not complete.
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| ID | Title | Description |
|---|---|---|
| FG000 | Suvorexant | 20mg Suvorexant |
| FG001 | Placebo | Placebo oral capsules |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Suvorexant | 20mg Suvorexant |
| BG001 | Placebo | Placebo oral capsules |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Opioid Use: Proportion of Positive Urine Drug Screens (UDS) | Opioid use (measured via uranalysis for qualitative opioid assay) other than prescribed methadone or buprenorphine at scheduled study visits up to 30 days post-randomization (yes vs. no) | One participant in the placebo group discontinued following randomization and did not have data collected. | Posted | Mean | Standard Deviation | Proportion of urine drug screens | Up to 30 days post-randomization |
|
From enrollment to end of follow-up, up to 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Suvorexant | 20mg Suvorexant | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Ellis | Johns Hopkins School if Medicine | 4105506346 | jellis36@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 19, 2024 | Nov 19, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D019966 | Substance-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C551624 | suvorexant |
| D000068796 | Orexin Receptor Antagonists |
| ID | Term |
|---|---|
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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The research pharmacy will manage all randomization and blinding.
| Placebo | Drug | Participants will be prescribed up to 30 days of placebo medication. |
|
| Total Sleep Time (TST) Regression Slope | Regression slope of TST scores over scheduled study visits up to 30 days post-randomization. | Up to 30 days post-randomization |
| Opioid Craving Visual Analog Scale (VAS) Regression Slope | Regression slope of opioid craving VAS scores over scheduled study visits through 30 days post-randomization. Score range 0-10 with higher score indicating worse craving. | Up to 30 days post-randomization |
| Cocaine Craving Visual Analog Scale (VAS) Regression Slope | Regression slope of cocaine craving VAS scores over scheduled study visits through 30 days post-randomization. Score range 0-10 with higher score indicating worse craving. | Up to 30 days post-randomization |
| Perceived Stress Scale Regression Slope | Regression slope of Perceived Stress Scale (PSS) scores over scheduled study visits through 30 days post-randomization. Total score range 0 to 40, with higher scores indicating worse perceived stress. | Up to 30 days post-randomization |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Insomnia Severity Index (ISI) | Total score (sum of items). Total possible range = 0-28. Higher scores reflect greater insomnia symptoms. | Mean | Standard Deviation | score on a scale |
|
| Total Sleep Time (TST) | Self-reported total sleep time. Higher scores reflect a longer total sleep time. (Range = 180-540 minutes) | Two participants (one in each group) do not have data collected on this scale at baseline | Mean | Standard Deviation | minutes |
|
| Opioid Craving Visual Analog Scale (VAS) | Total possible score = 0-100, Higher scores reflect higher opioid craving. | Mean | Standard Deviation | units on a scale |
|
| Cocaine Craving VAS, | Total possible score = 0-100, Higher scores reflect higher cocaine craving. | Mean | Standard Deviation | units on a scale |
|
| Perceived Stress Scale | Total score (sum of items). Total possible range = 0-40. Higher scores reflect greater perceived stress. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Cocaine Use: Proportion of Positive UDS Screens | Cocaine use (measured via uranalysis for qualitative cocaine assay) at scheduled study visits up to 30 days post-randomization. | One participant in the placebo group discontinued following randomization and did not have data collected. | Posted | Mean | Standard Deviation | Proportion of urine drug screens | Up to 30 days post-randomization |
|
|
|
| Secondary | Insomnia Severity Regression Slope | Regression slope of Insomnia Severity Index (ISI) scores over scheduled study visits through 30 days post-randomization. Total score range between 0-28 (absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). Higher score worse insomnia. | One participant in the placebo group discontinued following randomization and did not have data collected, leaving six participants in each group. | Posted | Number | 95% Confidence Interval | score on a scale/day | Up to 30 days post-randomization |
|
|
|
| Secondary | Total Sleep Time (TST) Regression Slope | Regression slope of TST scores over scheduled study visits up to 30 days post-randomization. | Two participants did not have baseline data on TST and could not be included in the analysis. One additional participant in the placebo group discontinued following randomization and did not have data collected. | Posted | Number | 95% Confidence Interval | score on a scale/day | Up to 30 days post-randomization |
|
|
|
| Secondary | Opioid Craving Visual Analog Scale (VAS) Regression Slope | Regression slope of opioid craving VAS scores over scheduled study visits through 30 days post-randomization. Score range 0-10 with higher score indicating worse craving. | One participant in the placebo group discontinued following randomization and did not have data collected. | Posted | Number | 95% Confidence Interval | score on a scale/day | Up to 30 days post-randomization |
|
|
|
| Secondary | Cocaine Craving Visual Analog Scale (VAS) Regression Slope | Regression slope of cocaine craving VAS scores over scheduled study visits through 30 days post-randomization. Score range 0-10 with higher score indicating worse craving. | One participant in the placebo group discontinued following randomization and did not have data collected. | Posted | Number | 95% Confidence Interval | score on a scale/day | Up to 30 days post-randomization |
|
|
|
| Secondary | Perceived Stress Scale Regression Slope | Regression slope of Perceived Stress Scale (PSS) scores over scheduled study visits through 30 days post-randomization. Total score range 0 to 40, with higher scores indicating worse perceived stress. | One participant in the placebo group discontinued following randomization and did not have data collected. | Posted | Number | 95% Confidence Interval | score on a scale/day | Up to 30 days post-randomization |
|
|
|
| 6 |
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | Placebo | Placebo oral capsules | 0 | 7 | 0 | 7 | 5 | 7 |
| Headache | General disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Appetite increased | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Toothache | General disorders | Systematic Assessment |
|
| Drowsiness | Nervous system disorders | Systematic Assessment |
|
| Skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment | Irritation from actigraph |
|
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| D000068776 | Sleep Aids, Pharmaceutical |
| D006993 | Hypnotics and Sedatives |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|